Study Evaluating Sirolimus in Kidney Transplant Recipients in India

Wyeth

Status and phase: Completed; Phase 4

Conditions: Kidney Failure; Graft vs Host Disease

Treatments: Drug: Rapamune

Study type: Interventional

Funder types: Industry

Identifiers

NCT00195481

0468H-101543

Details and patient eligibility

About

To determine the safety of sirolimus tablets in renal allograft recipients in a postmarketing surveillance setting.

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients in End Stage Renal Disease who are above 13 years of age and weigh more than 40 kilograms.
• Patients scheduled to receive a kidney from a cadaveric donor, from a living unrelated donor or from a living related donor.

Exclusion criteria

• Evidence of major infections at the time of sirolimus administration
• Use of any investigational drug or treatment up to 4 weeks prior to enrolling in the study and during the treatment phase.
• Females who are pregnant, breast feeding or in reproductive age group and not using a medically acceptable form of contraception

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)